—#53273

Product

Brilliance CT Systems, 40 slice configuration. Computed tomography scanner.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033326
Affected lot / code info: Model No. 728231. Version 2.2.1

Why it was recalled

Two potential artifacts may appear in some images from head scans on the Brilliance 40/64 systems. These artifacts may lead to misdiagnosis.

Root cause (FDA determination)

Software design

Action the firm took

Firm notified its customers via a Product Safety Notification letter dated May 25, 2007, warning the user of a possible appearance of artifacts which could lead to a misdiagnosis and improper treatment.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Worldwide, including USA, Canada, Argentina, Austria, Australia, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Denmark, Ecuador, Egypt, England, Equatorial Guinea, Finland, France, Germany, Greece, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Korea, Lebanon, Libya, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Phillipines, Poland, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, Uzbekistan, Venezuela, and West Indies.

Timeline

Recall initiated: 2007-05-25
Posted by FDA: 2007-10-31
Terminated: 2012-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53273. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.